Investigation of the Effectiveness of a Video-Based Exercise (Exergame) Program in Women With Fibromyalgia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Revised Fibromyalgia Impact Questionnaire
研究概览
简要总结
The goal of this clinical trial is to compare the effects of an exergame-based exercise program and a home-based exercise program in women aged 30-70 years diagnosed with fibromyalgia (FM).
The main questions it aims to answer are:
Does an exergame-based program using the Nintendo Switch game Ring Fit Adventure improve pain, balance, and functional mobility in women with fibromyalgia? Is the exergame program more effective than a traditional home-based exercise program in improving physical and psychosocial outcomes? Researchers will compare the exergame group and the home-based exercise group to determine whether game-based exercises provide superior benefits in pain reduction, balance, and quality of life.
Participants will:
Be randomly assigned to either the exergame or the home-based exercise group. Exercise twice a week for four weeks under the supervision of a physiotherapist or via remote monitoring.
Undergo evaluations before and after the 4-week training period, and again after a 4-week detraining period.
Assessments will include:
Pain intensity (Visual Analog Scale) Disease severity (Revised Fibromyalgia Impact Questionnaire, Widespread Pain Index, Symptom Severity Scale, Fibromyalgia Severity Scale) Lower extremity strength (Sit-to-Stand Test) Functional mobility (Timed Up and Go Test) Balance (Single-Leg Stance Test, Berg Balance Scale) Psychosocial status (Cognitive Exercise Therapy Approach Questionnaire - BETY-BQ) Quality of life (Short Form-12) Study findings are expected to provide evidence for the effectiveness of exergame applications as an enjoyable rehabilitation approach for individuals with fibromyalgia.
详细描述
Fibromyalgia (FM) is a chronic disorder characterized by widespread pain, tenderness in specific musculoskeletal regions, fatigue, sleep disturbances, headaches, cognitive dysfunction, muscle weakness, postural instability, altered gait, and an increased risk of falls. Exercise has been reported to be one of the most effective non-pharmacological treatments for FM, and various types of exercise have been proposed. However, the evidence regarding which type of exercise provides optimal benefit remains limited.
Recently, exergame-based exercises - video game-assisted physical activities that combine interactive gaming with exercise - have gained attention as a novel and motivating rehabilitation approach. These programs have been shown to enhance adherence and engagement in different populations, including healthy adults, older individuals, and patients with neurological and musculoskeletal conditions. Nevertheless, research on the use of exergames in individuals with fibromyalgia is scarce, and no studies have been identified that use the Nintendo Switch Ring Fit Adventure game in this population.
This randomized clinical trial aims to compare the effects of an exergame-based exercise program and a home-based exercise program in women diagnosed with fibromyalgia. Participants will be randomly assigned to one of two groups: (1) the exergame group, performing supervised exercises using Ring Fit Adventure twice a week for four weeks, and (2) the home-based exercise group, performing a physiotherapist-prescribed home exercise program twice a week for four weeks.
All participants will be evaluated at baseline and after the 4-week intervention period, and reassessed following a 4-week detraining phase. Data obtained from this study will contribute to understanding the effects of exergame applications on pain, balance, functional mobility, and psychosocial outcomes in women with fibromyalgia. The results are expected to provide evidence supporting the use of exergame-based exercises as an enjoyable and effective approach within rehabilitation programs for individuals with fibromyalgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 30 and 70 years, which is an age range in which fibromyalgia (FM) is more prevalent;
- •Having a diagnosis of fibromyalgia;
- •Being willing to participate in the study and signing the informed consent form;
- •Meeting the 2016 American College of Rheumatology (ACR) diagnostic criteria, defined as a Widespread Pain Index (WPI) ≥ 7 and a Symptom Severity Scale (SSS) score ≥ 5, or WPI = 4-6 and SSS ≥ 9.
排除标准
- •Pregnancy or breastfeeding
- •Any known advanced pathology related to the locomotor system that contraindicates physical activity (such as arthritis, osteoarthritis, or uric acid disorders)
- •History of severe headache
- •Neurological disorder
- •Peripheral neuropathy
- •Known severe cardiovascular disease (such as endocranial hypertension, uncontrolled arterial hypertension, heart failure, or presence of a pacemaker)
- •Orthopedic disorders of the upper or lower extremities that prevent participation in physical activity
- •Rheumatologic disease other than fibromyalgia
- •Pneumothorax
- •Neoplasia
- •Surgery within the last four months
- •Severe psychiatric illness (such as uncontrolled depression and anxiety, personality disorders, dementia, or cognitive impairments related to substance abuse)
- •Diagnosis of alcohol dependence or use of psychoactive drugs or narcotics
- •Participation in any physical activity program within two months prior to the start of the study
- •Body mass index (BMI) greater than 29.9
结局指标
主要结局
Revised Fibromyalgia Impact Questionnaire
时间窗: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
The Revised Fibromyalgia Impact Questionnaire will be used to assess the impact of fibromyalgia (FM) on patients. The questionnaire consists of 21 items. All items are based on an 11-point numerical rating scale ranging from 0 to 10, where 10 indicates the worst possible condition. It comprises three domains: function, overall impact, and symptoms. The total score for the function domain (range 0-90) is divided by 3; the overall impact domain (range 0-20) is left unchanged; and the total score for the symptom domain (range 0-100) is divided by 2. The overall Revised Fibromyalgia Impact Questionnaire score is the sum of these three domain scores.
Fibromyalgia Severity Scale
时间窗: Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up
The Fibromyalgia Severity Scale is calculated by summing the scores of the Widespread Pain Index (WPI) and the Symptom Severity Scale (SSS). The maximum total score is 31 (19 + 12 = 31). A total score below 12 is generally not considered indicative of fibromyalgia.
次要结局
- 30-Second Sit-to-Stand Test(Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up)
- Visual Analog Scale (VAS)(Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up)
- Timed Up and Go Test(Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up)
- Single-Leg Stance Test(Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up)
- Berg Balance Scale(Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up)
- Cognitive Exercise Therapy Approach Scale (BETY-BQ)(Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up)
- Short Form-12 (SF-12)(Assessed at baseline, post-intervention (4 weeks), and at 8-week follow-up)